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Health of Patients with Nonalcoholic Steatohepatitis Improved Through Treatment with Anti-CD3 Antibodies
Date:11/7/2011

SAN FRANCISCO, Nov. 7, 2011  /PRNewswire/ -- Nonalcoholic steatohepatitis (NASH) is a major cause of cirrhosis and is growing in incidence in the United States. By treating patients with NASH with orally administered anti-CD3 monoclonal antibodies, researchers at Hadassah Medical Center and NasVax Ltd in Israel were able to improve clinical biomarkers for insulin resistance as well as liver enzyme levels.

The presentation of the study at The Liver Meeting®, the annual meeting of the American Association for the Study of Liver Diseases (Monday, November 7), is on the results of a phase IIa blinded, placebo-controlled trial. Previous studies in animal models showed improvement in inflammation and autoimmunity. The purpose of this clinical trial was to determine safety and trends in clinical biomarkers and immune-modulation in patients with NASH.

The 36 subjects received one of three dosage levels of oral antibody immunotherapy or placebo once daily for 30 days, followed by an additional 30 days of observation. In addition to assessing a broad range of safety parameters, patients were tested for liver enzymes, glucose, lipid profile, oral glucose tolerance, serum cytokines, and regulatory T cells. Treatment was safe and very well tolerated, and no treatment-related adverse events were noted for any of the patients.

Because of the positive results of the study, lead researcher Dr. Mizrahi, said, "We think that these data are promising for the treatment of inflammatory diseases. The mechanism of action, which is the induction of regulatory T cells for the suppression of inflammation, is distinct from other therapies that have been investigated to date. Consequently we have intensified our effort to progress further clinical development in NASH and complete the ongoing Phase IIa trial in Hepatitis C."

Abstract title:

Oral administration of anti-C03 MAb to patients with NASH is safe, promotes regulatory T cells, decre
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SOURCE American Association for the Study of Liver Diseases (AASLD)
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